Burzynski Page #11

pharmaceutical company entered the picture

-Elan Pharmaceutical, our consultant Dr. Samid became too close.

She really became a consultant for Elan Pharmaceutical

and she was working with Elan from this time.

And suddenly, Elan Pharmaceuticals terminated their

licensing agreement, stating...

Elan has significant doubt as to whether the active substances

comprising of Antineoplastons have patent protection,

thereby rendering an agreement meaningless.

Antineoplastons are not just one chemical.

We have different ingredients in Antineoplastons.

One of these ingredients was known before.

We discovered that this was the metabolite of Antineoplastons,

and it was known and it was available before.

So when we patented our invention, our lawyers told us

"look, you can't patent this particular ingredient

because it was known before

let's list it in your patents, but don't patent this

because you will never get a patent for that."

But this is the least important ingredient of Antineoplastons.

While this was an odd turn of events

more good news continued to pour in!.

It was in October 1991 when Dr. Nicholas Patronas

led the National Cancer Institute on their site visit,

the very same site visit Dr. Patronas would later base

his testimony when defending Burzynski against

the Texas Medical Board.

This site visit not only confirmed that Antineoplastons

were curing what was previously considered incurable brain cancer,

but, it garnered their interest in conducting a confirmatory trial under

Division of Cancer Treatment sponsorship

at the National Cancer Institute.

These trials involved most of their top experts,

including, Dr. Michael Friedman:

the Associate Director of the Cancer Therapy Evaluation Program.

In a memo addressed to his director, Dr. Friedman wrote:

"l thought you would be interested in this."

"Antineoplastons deserve a closer look."

"It turns out that the agents are well-defined, pure chemical entities.

The human brain tumor responses are real."

The National Cancer Institute's "Decision Network" then convened,

and gave the green light to conduct government-sponsored

clinical trials of Antineoplastons.

Initially everybody was very excited about it,

everybody wanted to proceed, the people who reviewed our results

-the experts from the NCI, they did a very good job.

They were critical of course, but they were also highly complimentary

for the way we treated patients and the results we got.

It looked like everything should open and move forward.

Suddenly everything came to a stop.

And then we found that a few months later Elan received

permission to do clinical trials with this particular ingredient.

Ours was pushed back for about four years,

and Elan was allowed to proceed with theirs suddenly.

When Elan terminated their business deal with Burzynski,

they went behind his back, recruited Dr. Dvorit Samid,

and partnered with the National Cancer Institute,

where Dr. Samid soon became a section chief.

Elan then co-sponsored laboratory research and clinical

trials testing only this single ingredient, called: "Phenylacetate"

-the same chemical that Burzynski was advised he couldn't patent,

and had already proven to be quite limited against cancer

as a single substance as far back as 1980.

After the treatment in a small number of patients

we found that the activity was quite limited.

That's why I decided to abandon phenylacetate,

and we use the other Antineoplastons.

One of them contains phenylacetate as the second ingredient.

In 1994, I started working for Dvorit Samid.

She didn't let me know that those compounds were from Dr. Burzynski.

She just said "phenylacetate",

and she showed me all of the published papers about phenylacetate,

and its analogs and their anti-cancer activity.

It was quite amazing in the lab,

because if you find a compound that has anti-cancer activity,

and then you find a bunch of analogs,

it's like stumbling upon a pile of gold.

So people would think and they'd say:

"patents" "patents" "patents"

you know that sort of thing.

With Dvorit, under her leadership,

we found a lot of biological activities in these compounds,

that have anti-cancer activity.

The scientists at Johns Hopkins tried to patent these compounds,

but of course Dvorit was working with

Elan Pharmaceutical company at that time,

so those guys at Johns Hopkins didn't have any chance of

patenting these compounds.

It's interesting that she would complain in the lab,

saying that "these guys tried to go behind her back

and patent these compounds".

While Burzynski was facing continuous harassment from state and

federal agencies, the earliest phenylacetate studies were published

in April of 1992,

authored by Dvorit Samid, hosted by the National Cancer Institute.

Burzynski sat in awe as he witnessed the National Cancer Institute

recruit one of his researchers, push his research aside,

and begin to test phenylacetate without him, reporting:

...phenylacetate is both effective in inducing tumor cell maturation

and free of cytotoxic and carcinogenic effects, a combination that

warrants attention to its potential use in cancer intervention.

In 1995, in the lab, I was still with Dvorit,

but I smelled [something] fishy.

something was not right

The first paper Dvorit published about phenylacetate,

if you look at the "methodology" section,

there's a "BRI" abbreviation.

She got materials from the Burzynski Research Institute - Huston, TX.

but it didn't say "Burzynski Research Institute".

For us as scientists,

It's a "funny practice".

Burzynski's name failed to appear in the acknowledgments,

or any of the references listed in this report.

Burzynski knew these tests would fail since he had already

proven this in his own laboratory twelve years before.

Abandoned by the National Cancer Institute, he sat powerless on

the sidelines as the attempted high-jacking of his discovery

unfolded before his eyes, ending in the hideous train wreck

he warned them it would.

The National Cancer Institute, Elan, and Dr. Samid spent over

four years and tens of millions of dollars testing phenylacetate.

Phenylacetate by itself has very little clinical effect.

and the NCI or Elan could not use the other

ingredients of Antineoplastons

because they were covered by the patents owned by me.

They were tying to commercialize this, but without

the other ingredients they couldn't do much with this.

This needed to be given in conjunction with the others.

While coming to terms with this reality,

the National Cancer Institute decided to honor

the government sponsored clinical trials of Antineoplastons

they had initially promised Burzynski in 1991.

From the moment this dialogue was re-opened, the National Cancer

Institute proposed altering the treatment protocols that Burzynski

had spent 20 years perfecting.

Burzynski told them, that until they agree to a protocol that he has

confidence in, he was not going to provide the National Cancer

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